The FDA is beefing up its inspection staff in India by nearly 60%, adding to its oversight capabilities even as it has taken severe action against some of the country's largest drugmakers. The agency got its wallet fattened this fiscal year so that it could expand in countries like India and China, which are now some of the biggest producers of drugs and active pharmaceutical ingredients (APIs).
The FDA is adding 7 people to its India office, bringing the total to 19, FDA spokesman Christopher Kelly told the PTI news service, The Economic Times reports. Ten of the 19 staff members handle pharma oversight while others are dedicated to medical devices or food, he said. "Having these additional inspectors in-country will assist the agency in meeting our legislative mandates. So we are increasing our rates of inspection," Kelly added. "We are currently recruiting and training staff for these positions."
The new Generic Drug User Fee Amendments (GDUFA) require generic drugmakers to kick in fees to help cover the costs of more inspections and faster drug approvals. For its part, the agency must catch up foreign inspections within the first 5-year user-fee authorization period, bringing them in line with the schedule it keeps for U.S. companies. And since India is the second largest producer of finished drugs to the U.S., it is receiving much of the attention.
Kelly said staff are there not only to inspect companies but also to "collaborate" with Indian regulators so both countries can stretch resources. He said the agency believes many Indian manufacturers are following current Good Manufacturing Practices but "will take appropriate action if, or when, lapses, occur."
And they have been occurring recently in the plants of some of India's largest players. The agency last week announced an import alert against a third Ranbaxy Laboratories plant in India, after finding a long list of quality and sanitary shortcomings. The company says it has started steps to resolve the issues, but the FDA says its products will be banned from the U.S. until it is satisfied the plant is up to par. Two other Ranbaxy plants have been banned from shipping since 2009. It took the same action against a Wockhardt plant in May and two RPG Life Sciences facilities in June after discovering plant management at those operations had falsified some drug-testing data to cover up batch failures, among other problems.
- read the Economic Times story